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Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO)

NCT ID: NCT01396083

Last Updated: 2016-09-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-01-31

Brief Summary

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This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant® after 6 months of treatment. In the study arm Lucentis will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards.

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Detailed Description

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Conditions

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Visual Impairment Macular Edema Central Retinal Vein Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ranibizumab

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

Standard of Care

Group Type ACTIVE_COMPARATOR

Dexamethasone implant and sham injections

Intervention Type DRUG

Interventions

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Ranibizumab

Intervention Type DRUG

Dexamethasone implant and sham injections

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with visual impairment due to macular edema following CRVO
* Diagnosis of CRVO at maximum 6 months prior to Screening
* BCVA using ETDRS charts of 20/40 to 20/400 in the study eye

Exclusion Criteria

* Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs
* Central retinal thickness (CRT) \< 250 µm in the study eye
* Prior episode of RVO in the study eye
* Active formation of new vessels in the study eye
* Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline
* IOP ≥ 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment
* Improvement of \> 10 letters on BCVA between Screening and Baseline
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Leipzig, Germany, Germany

Site Status

Novartis Investigative Site

Regensburg, Germany, Germany

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Novartis Investigative Site

Augsburg, , Germany

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Bad Rothenfelde, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bonn, , Germany

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Bremen, , Germany

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Chemnitz, , Germany

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Cologne, , Germany

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Darmstadt, , Germany

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Dortmund, , Germany

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Dresden, , Germany

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Düsseldorf, , Germany

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Frankfurt, , Germany

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Freiburg I. Br, , Germany

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Glauchau, , Germany

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Göttingen, , Germany

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Hagen, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Homburg, , Germany

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Ingolstadt, , Germany

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Karlsruhe, , Germany

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Karlsruhe, , Germany

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Kiel, , Germany

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Lauterbach, , Germany

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Ludwigshafen, , Germany

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Minden, , Germany

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Mülheim, , Germany

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München, , Germany

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München, , Germany

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Münster, , Germany

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Münster, , Germany

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Nuremberg, , Germany

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Recklinghausen, , Germany

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Sulzbach, , Germany

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Tübingen, , Germany

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Ulm, , Germany

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Wolfsburg, , Germany

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Würzburg, , Germany

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Budapest, , Hungary

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Budapest, , Hungary

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Szeged, , Hungary

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Bydgoszcz, , Poland

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Bytom, , Poland

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Birmingham, , United Kingdom

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Birmingham, , United Kingdom

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Bradford, , United Kingdom

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Cheshire, , United Kingdom

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Colchester, , United Kingdom

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Derby, , United Kingdom

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Gloucester, , United Kingdom

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Guildford, Surrey, , United Kingdom

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Kent, , United Kingdom

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Leeds, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Middlesbrough, , United Kingdom

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Nottingham, , United Kingdom

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Portsmouth, , United Kingdom

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Rugby, , United Kingdom

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Novartis Investigative Site

Westcliff-on-Sea, , United Kingdom

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Novartis Investigative Site

York, , United Kingdom

Site Status

Countries

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Germany Hungary Poland United Kingdom

Other Identifiers

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2011-001020-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRFB002EDE18

Identifier Type: -

Identifier Source: org_study_id

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